PIONEER PLUS CATHETER

Additional Manufacturer Narrative

BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED INTACT TO TWO (2) GUIDEWIRES. ONE (1) GUIDEWIRE WAS STUCK IN THE LUER, BUT WAS ABLE TO BE REMOVED. THE SECOND (2) GUIDEWIRE WAS BENT AND STUCK AT THE DISTAL TIP, AND COULD NOT BE REMOVED. VISUAL INSPECTION OF THE CATHETER FOUND THE NEEDLE WAS NOT DEPLOYED; THEREFORE, NO SHARP EDGE WAS OBSERVED. ADDITIONALLY, THE GUIDEWIRE EXIT PORT WAS DAMAGED, EXPOSING THE POLYAMIDE MATERIAL. DURING FUNCTIONAL TESTING, A NEEDLE DEPLOYMENT/RETRACTION TEST WAS PERFORMED; HOWEVER, IT FAILED DUE TO RESISTANCE. BLOCK H6: THE PROBABLE CAUSE OF THE NEEDLE UNABLE TO DEPLOY/RETRACT IS DUE TO USE/HANDLING AS EVIDENCE BY THE DAMAGED GUIDEWIRE. DEVICE MANIPULATION, IMPACT, AND HANDLING CAN FURTHER AFFECT THE INTEGRITY OF THE DEVICE. BLOCKS H7, H9 AND H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION PERFORMED. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING REMOVAL, THE NEEDLE INSIDE THE CATHETER COULD NOT BE RETRACTED. AN ATTEMPT TO RETRACT THE NEEDLE WAS UNSUCCESSFUL DUE TO THE KINKED GUIDEWIRE THAT BECAME STUCK; THEREFORE, REMOVED ALL TOGETHER. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE AND REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.